EFSA Journal最新文献

{"title":"Epidemiological analysis of African swine fever in the European Union during 2024","authors":"European Food Safety Authority (EFSA),&nbsp;Karl Ståhl,&nbsp;Anette Ella Boklund,&nbsp;Tomasz Podgórski,&nbsp;Timothée Vergne,&nbsp;Roxani Aminalragia-Giamini,&nbsp;José Cortiñas Abrahantes,&nbsp;Stella Papaleo,&nbsp;Lina Mur","doi":"10.2903/j.efsa.2025.9436","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9436","url":null,"abstract":"<p>During 2024, the number of EU Member States affected by African swine fever (ASF) decreased from 14 to 13, with Sweden regaining freedom and no new Member State becoming infected. ASF outbreaks in domestic pigs in the EU declined by 83% compared to 2023, primarily due to fewer outbreaks in Croatia and Romania, although Romania notified 66% of the 333 outbreaks in the EU. Most outbreaks (78%) occurred in establishments with fewer than 100 pigs. However, an increase in outbreaks in establishments with more than 100 pigs was observed in Italy and Poland. Like previous years, there was a clear seasonality for domestic pig outbreaks, with 51% of them notified between July and September. Most of the outbreaks in domestic pigs were detected through passive surveillance based on clinical suspicion (79.4%), while fewer outbreaks were detected through enhanced passive surveillance involving systematic testing of dead pigs (14.2%) and 6.4% through tracing contacts after outbreak detection. In wild boar, the number of outbreaks notified has remained stable since 2022 (between 7000 and 8000) with a less clear seasonality than for domestic pigs, and a winter peak observed only in Hungary, Italy, Poland and Slovakia. Overall, 29% of the 23,919 wild boar carcasses found during passive surveillance activities tested positive for ASFv by PCR, representing 70.4% of the wild boar outbreaks in the EU. In contrast, around 0.4% of the 412,753 hunted wild boar tested positive by PCR, representing 28.4% of the wild boar outbreaks. While the use of serological tests performed in wild boar decreased, the number of PCR tests remained stable. Despite the reduction in the number of outbreaks in domestic pigs, the total size of the restricted zones III in the EU remained stable, with a slight increase in restricted zones II + III in 2024.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9436","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme pullulanase from the non-genetically modified Klebsiella pneumoniae strain AE-PUL","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Silvia Peluso,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Ana Criado,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9332","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9332","url":null,"abstract":"<p>The food enzyme pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced by Amano Enzymes Inc. with the non-genetically modified <i>Klebsiella pneumoniae</i> strain AE-PUL, a known human pathogen. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in 10 food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.075 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 0 124 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the pullulanase to known allergens was made and matches with two food allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9332","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme 4-α-glucanotransferase from the genetically modified Bacillus amyloliquefaciens strain MAS","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Simone Lunardi,&nbsp;Magdalena Andryszkiewicz,&nbsp;Giulio Di Piazza,&nbsp;Natalia Kovalkovicova,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9420","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9420","url":null,"abstract":"<p>The food enzyme 4-α-glucanotransferase (1,4-α-<span>d</span>-glucan:1,4-α-<span>d</span>-glucan 4-α-<span>d</span>-glycosyltransferase; EC2.4.1.25) is produced with the genetically modified <i>Bacillus amyloliquefaciens</i> strain MAS by Koninklijke Cooperatie Avebe U.A. The production strain contains multiple copies of known antimicrobial resistance genes. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in the production of enzymatically treated starch. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 83,333. A search for homology of the amino acid sequence of the 4-α-glucanotransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9420","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;José Manuel Barat Baviera,&nbsp;Gisela Degen,&nbsp;David Gott,&nbsp;Lieve Herman,&nbsp;Jean-Charles Leblanc,&nbsp;Peter Moldeus,&nbsp;Ine Waalkens-Berendsen,&nbsp;Detlef Wölfle,&nbsp;Civitella Consuelo,&nbsp;Borana Dino,&nbsp;Simone Lunardi,&nbsp;Agnieszka Mech,&nbsp;Salvatore Multari,&nbsp;Camilla Smeraldi,&nbsp;Alexandra Tard,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2025.9396","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9396","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme-catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in the definition. Rebaudioside M is produced via enzymatic bioconversion from Stevia leaf extract, using the genetically modified yeast strain <i>K. phaffii</i> CGMCC 7539. The final product is composed mostly of rebaudioside M (&gt; 97%) and a mixture of rebaudiosides A, B and D at various concentrations. The Panel considered that the proposed amendment of the specifications is justified with respect to the inclusion of a new microorganism strain, taking into account that the manufacturing process and the submitted analytical data are already covered by the parameters listed in the existing EU specifications for E 960c(i) and E 960c(ii). The Panel considered that it is in the remit of the risk managers to decide whether the proposed changes in the specifications should result in an amendment of the already existing EU specifications of E960c(i) or E960c(ii). Viable cells and DNA from the production strain are not present in the final product; hence, the manufacturing process does not raise a safety concern. The Panel considered that the proposed food additive has the same physicochemical characteristics of E 960c(i) or E 960c(ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of Rebaudioside M produced from <i>K. phaffii</i> CGMCC 7539. The Panel concluded that there is no safety concern with respect to the proposed amendment to the EU specifications of E 960c(i) or E 960c(ii) related to the use of the new genetically modified strain <i>K. phaffii</i> CGMCC 7539 in the manufacturing process of the food additive Rebaudioside M produced via enzyme-catalysed bioconversion.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9396","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 2023 European Union report on pesticide residues in food","authors":"European Food Safety Authority (EFSA),&nbsp;Luis Carrasco Cabrera,&nbsp;Giulio Di Piazza,&nbsp;Bruno Dujardin,&nbsp;Emanuela Marchese,&nbsp;Paula Medina Pastor","doi":"10.2903/j.efsa.2025.9398","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9398","url":null,"abstract":"<p>Under European Union legislation (Article 32, Regulation (EC) No 396/2005), the European Food Safety Authority publishes an annual report assessing the pesticide residue levels in food. In 2023, as part of the EU-coordinated multiannual control programme subset, 13,246 samples placed on the European market were analysed, with a 1.0% found to be non-compliant. Risk-based sampling procedures were used for the remaining 132,793 samples with a 2.0% non-compliant rate. Both dietary acute and chronic risk to consumers' health were estimated providing the probabilities of exceedance of the health-based guidance values (HBGV) for the pesticides in food by the different subpopulation of European consumers. This meant dropping the deterministic assessment used in the past. Overall, the dietary risk was found to be very low for most of the EU subpopulation groups. Recommendations were provided to risk managers to increase the effectiveness of European control systems and to ensure a high level of consumer protection throughout the EU.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9398","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of yellow tomato extract as a novel food pursuant to Regulation (EU) 2015/2283","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),&nbsp;Dominique Turck,&nbsp;Torsten Bohn,&nbsp;Montaña Cámara,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan De Henauw,&nbsp;Ángeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Harry J. McArdle,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Margarita Aguilera-Gómez,&nbsp;Francesco Cubadda,&nbsp;Thomas Frenzel,&nbsp;Marina Heinonen,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Helle Katrine Knutsen,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Ruth Roldán-Torres,&nbsp;Wolfgang Gelbmann,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9373","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9373","url":null,"abstract":"<p>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on yellow tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid-rich extract from the yellow tomato containing predominantly phytoene plus phytofluene (PE/PF) at up to 10% of the NF, as well as a lesser amount of zeta-carotene (≤ 5%), beta-carotene (≤ 0.5%) and lycopene (≤ 0.4%). The NF is produced from the tomato pulp using supercritical CO₂ extraction. The applicant proposes to use the NF in food supplements (FS) for adults only at a maximum daily dose of 100 mg. The intake of lycopene from such FS would correspond to 0.4 mg/day which corresponds to 5.7 μg/kg body weight and day for an adult weighing 70 kg. This is approximately 1.1% of the acceptable daily intake (ADI) for lycopene established by EFSA (i.e. 0.5 mg/kg body weight), which does not raise safety concerns. According to the exposure assessment performed by EFSA, which included all population age groups, the highest mean and highest P95 intakes/kg bw estimates for PE/PF from the background diet of infants and toddlers are higher than the combined exposure of adults from the background diet and the NF under its proposed use and use levels in food supplements. Noting that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that PE/PF exposure from the background diet does not raise safety concern, the Panel considers that the NF is nutritionally not disadvantageous at the proposed intake of the NF of up to 100 mg/day used in FS in adults. The Panel concludes that the NF, yellow tomato extract, is safe under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9373","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revised safety evaluation of the food enzyme leucyl aminopeptidase from the non-genetically modified Aspergillus sp. strain AE-MB","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Eleonora Marini,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9422","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9422","url":null,"abstract":"<p>The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain AE-MB by Amano Enzyme Inc. In a previous evaluation, the Panel concluded that the food enzyme could not be considered safe when used in five food manufacturing processes, due to insufficient margins of exposure estimated for all age groups. Subsequently, the applicant requested to withdraw one use, to include three additional food manufacturing processes, and to revise the use levels. In the present assessment, EFSA revised the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.367 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level reported in the previous opinion (183 mg TOS/kg bw per day, the lowest dose tested), the revised margin of exposure was at least 499. Having integrated new data into the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9422","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21234)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Ana M. Camargo,&nbsp;Paolo Lenzi,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9377","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9377","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21234 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified cotton MON 88913, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in cotton MON 88913 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21234 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton MON 88913.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9377","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of genetically modified soybean MON 87708 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21237)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Ana M. Camargo,&nbsp;Paolo Lenzi,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9379","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9379","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21237 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant genetically modified soybean MON 87708, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean MON 87708 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21237 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87708.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9379","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of genetically modified maize MON 87427 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21254)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Ana M. Camargo,&nbsp;Paolo Lenzi,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9380","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9380","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21254 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the of tissue-selective herbicide-tolerant genetically modified maize MON 87427, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 87427 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21254 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 87427.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9380","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}